Plain English Summary
Background and study aims
Lower back pain is a common problem, which affects most people at some point in their lives. Many people who experience LBP will recover quickly with no significant impact to their lives, but for some people the pain turns into a long term condition which can affect their ability to work. When a sufferer experiences episodes which last for at least three months, it is known as chronic lower back pain (CLBP). For some patients, their CLBP is caused by inflammation (swelling) in the vertebrae (small bones which make up the spite). Adalimumab is a medication used in patients with inflammatory conditions such as arthritis, as it works by reducing inflammation. The aim of this study is to investigate the effectiveness of treating patients who have CLBP caused by inflammation with adalimumab.
Who can participate?
Adults with CLBP which is caused by inflammation.
What does the study involve?
All participants receive a subcutaneous injection (injection under the skin) of 40mg Adalimumab every other week for 12 weeks. During this time, and for two weeks after the end of treatment, participants are askedto keep a record of any pain medication they take, which is reviewed at the start of the study, each time they have an injection and two weeks after the end of treatment. At the start of the study and then after 12 weeks, participants complete a number of questionnaires to assess their pain levels and disability. In addition, participants also have an MRI scan at the start of the study and after 12 weeks to measure the swelling (inflammation) in their spine).
What are the possible benefits and risks of participating?
Participants may benefit from a reduction in pain and disability. There is a small risk that participants may be more vulnerable to developing an infection while taking the study drug.
Where is the study run from?
1. University Hospital of Geneva (Switzerland)
2. HFR- Fribourg Cantonal Hospital (Switzerland)
When is the study starting and how long is it expected to run for?
July 2010 to January 2015
Who is funding the study?
1. University Hospital of Geneva (Switzerland)
2. AbbVie (USA)
Who is the main contact?
Dr Stéphane Genevay
stephane.genevay@hcuge.ch
Study website
Contact information
Type
Scientific
Contact name
Dr Stéphane Genevay
ORCID ID
http://orcid.org/0000-0003-4752-3186
Contact details
Division of Rheumatology
University Hospitals of Geneva
Geneva
1211
Switzerland
+41 223 723 673
stephane.genevay@hcuge.ch
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
CE 10 139
Study information
Scientific title
Anti-TNF treatment in patients with chronic low back pain associated with Modic I changes: An exploratory trial
Acronym
Study hypothesis
Adalimumab could be a potentiel treatment for low back pain patient with Modic I endplate changes.
Ethics approval(s)
1. Ethical committee of Geneva University Hospital, 09/11/2011, ref: 10-139
2. Swissmedic, 16/12/2011, ref: 2011DR2213
Study design
Pilot one-arm non-randomised study
Primary study design
Interventional
Secondary study design
Non randomised study
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Chronic low back pain patient with inflammatory pain pattern and Modic I endplate changes
Intervention
All patients receive a subcutaneous injection of Adalimumab 40mg every other week for 12 weeks.
Participants are asked to keep a pain medication diary from baseline until 2 weeks after the intervention, which is reviewed at baseline and then every 2 weeks until the final follow up 2 weeks after the intervention ends. Participants complete follow up questionnaires and undergo MRI scanning at 12 weeks.
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Phase IV
Drug/device/biological/vaccine name(s)
Adalimumab (Humira)
Primary outcome measure
Pain is measured using a numerical rating scale (NRS) and the Roland Disability Questionnaire (RDQ) at baseline and 12 weeks.
Secondary outcome measures
1. Morning stiffness is measured using a numerical rating scale (NRS) at baseline and 12 weeks
2. Quality of sleep is measured using a numerical rating scale (NRS) at baseline and 12 weeks
3. Patient Global Improvement is measured using a numerical rating scale (NRS) at baseline and 12 weeks
4. Function is measured using Bath Ankylosing Spondilitis disease activity index (BASDAI) at baseline and 12 weeks
5. Health related quality of life is measured using the EuroQol-5 dimensions (EQ-5D) at baseline and 12 weeks
6. Pain medication taken is measured using the Pain Medication Diary at baseline and then every 2 weeks until 2 weeks post-intervention
7. Duration of sick listing is measured by questionnaire at baseline and 2 weeks post-intervention
8. Size of bone oedema is measured using MRI (Modic I) at baseline and 12 weeks
Overall study start date
07/07/2010
Overall study end date
23/01/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age 18-65 years
2. Signed Informed Consent
3. Common low back pain
4. The presence of 2 out of 3 of the following points, indicating inflammatory back pain:
4.1. Insidious onset
4.2. Morning stiffness
4.3. Improvement with exercise
5. Continuous pain for more than 3 months
6. Failure of at least one full course of non steroidal anti-inflammatory drug
7. Pain > 3/10 on a 0 to 10 numeric rating scale over the last 24 hours
8. At least one Modic I modification on lumbar MRI
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Upper age limit
65 Years
Sex
Both
Target number of participants
25
Participant exclusion criteria
1. A diagnosis of spondylarthropathy following standard definition
2. Either : Presence of sacroiliitis on imaging
or At least 2 of the following
Inflammatory Bowel Disease, Arthritis, Enthesitis, Dactylitis, Uveitis, Psoriasis, Family history of spondylarthropathy, Elevated CRP or sedimentation rate
3. Radicular pain related to disc herniation
4. Neurogenic claudication related to lumbar stenosis
5. Comorbidities impairing with the evaluation of pain or function
6. Concomitant infection
6.1. In case of tuberculosis (positive TBspot) at least one month of antituberculosis treatment is required before considering inclusion
6.2. Active Hepatitis B infection (screening for active HBV infection will be performed)
7. Women of child-bearing age refusing to use contraceptive measure during the study, Pregnancy (pregnancy test will be performed before inclusion), breastfeeding
8. Heart failure (NYHA III and IV)
9. Current treatment with corticosteroids
10. Prior exposure to anti-TNF agents, including adalimumab
11. Inability to comply with the protocol requirements
12. Past history of cancer
13. Demyelinating diseases
14. Allergy to adalimumab or one of its components
15. Unable to read and understand the questionnaires (in French)
16. Poor motivation or other emotional or intellectual problems that are likely to limit the ability of the patient to comply with the protocol requirements
Recruitment start date
02/06/2013
Recruitment end date
24/10/2014
Locations
Countries of recruitment
Switzerland
Study participating centre
University Hospital of Geneva
Division of Rheumatology
Geneva
1211
Switzerland
Study participating centre
HFR- Fribourg Cantonal Hospital
Department of Rheumatology, Physical Medicine and Rehabilitation
Fribourg
1708
Switzerland
Sponsor information
Organisation
University Hospital of Geneva
Sponsor details
Perret-Gentil 4
Geneva
1211
Switzerland
Sponsor type
Hospital/treatment centre
Website
ROR
Funders
Funder type
Hospital/treatment centre
Funder name
University Hospital of Geneva
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
AbbVie
Alternative name(s)
AbbVie Inc., AbbVie U.S., AbbVie US, Allergan
Funding Body Type
government organisation
Funding Body Subtype
For-profit companies (industry)
Location
United States of America
Results and Publications
Publication and dissemination plan
Results will be presented in rheumatology and back pain congress. They will then be published in peer-reviewed journals.
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Available on request
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|